Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions

NCT ID: NCT02432066

Last Updated: 2019-03-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-29
• Study Completion Date: 2020-12-29

Brief Summary

Attempts to quit cigarette smoking are often accompanied by negative mood and problems in attention and memory. These effects, in turn, may contribute to smoking relapse. This exploratory/developmental project examines the effects of a novel medication, GTS-21, on individuals interested in smoking cessation. It is hypothesized that GTS-21 will reduce negative affect, improve cognition and/or reduce smoking relapse in healthy adult men and women who are chronic cigarette smokers.

Detailed Description

The project is a clinical trial assessing the effects of GTS-21 (an α7 nicotinic receptor partial agonist) on smoking, mood, neurocognition, and neurophysiology, in a small sample of chronic smokers who are currently healthy and interested in smoking cessation. Using a double-blind, placebo controlled, parallel group design, 54 (27 women) community smokers who have demonstrated a readiness to quit will participate over a 7 week active trial. Subjects will be randomly assigned to active drug or placebo groups. Across the study period, participants will undergo repeated neurobehavioral testing, laboratory assessments of cardiovascular and liver function, and provide weekly updates regarding smoking behavior, mood state and side-effects.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GTS-21

Participants in the GTS-21 arm will receive 150 mg/BID GTS-21 over the course of 7 weeks. All participants will receive repeated neurobehavioral testing, laboratory assessment of cardiovascular and liver function, and provide weekly updates regarding smoking behavior, mood states, and side effects.

Group Type: ACTIVE_COMPARATOR

GTS-21

Intervention Type: DRUG

GTS-21 is a partial alpha7 nicotinic agonist. GTS-21 will be compounded by the UF investigational pharmacy, and administered orally.

Placebo

Participants in the Placebo arm will receive placebo compound twice daily over the course of 7 weeks. All participants will receive repeated neurobehavioral testing, laboratory assessment of cardiovascular and liver function, and provide weekly updates regarding smoking behavior, mood states, and side effects.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral placebo pills, compounded by the UF investigational pharmacy

Interventions

GTS-21

GTS-21 is a partial alpha7 nicotinic agonist. GTS-21 will be compounded by the UF investigational pharmacy, and administered orally.

Intervention Type: DRUG

Placebo

Oral placebo pills, compounded by the UF investigational pharmacy

Intervention Type: DRUG

Other Intervention Names

3-(2,4-dimethoxybenzylidene) anabaseine (DMXB-A); Placebo Comparator

Eligibility Criteria

Inclusion Criteria

• Minimum of 12 years of education
• Must report typical daily smoking of > 10 cigarettes/day over the previous year
• Must report a history of at least 3 years of regular smoking
• Must provide carbon monoxide measures of at least 6.5 ppm
• Must report a willingness to quit smoking

Exclusion Criteria

• Participants engaged in behavioral and/or nicotine replacement therapies, or assisted quit efforts, within previous 6 months.
• Must not meet criteria for other substance dependence or major psychiatric disorders.
• Must be absent chronic medical conditions that might jeopardize health and safety, confound data interpretation or that contraindicate the administration of compounds acting at nAChR sites. This list includes disorders with direct effects on neurologic function (e.g., seizure disorders, transient ischemic events, chronic or active hepatic disease), metabolic disorders (e.g., uncontrolled Type 2 diabetes), or cardiovascular disease (e.g., hypertension, mitral valve compromise, tachycardia, or irregular heart rates).
• Must not smoke only cigars, pipes or hookahs or use nicotine products but not cigarettes
• Must not report current use of nicotine replacement therapies (i.e., occasions of > 4 h/week during a typical week, even if not used as a cessation aid)
• Must not have used bupropion within the previous year
• Must not report any past use (regardless of year) of varenicline
• Women may not be breastfeeding, pregnant or intending to become pregnant during the study period

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sara J Nixon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Other Identifiers

Nixon2015

Identifier Type: OTHER

Identifier Source: secondary_id

R21DA038286

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201500393

Identifier Type: -

Identifier Source: org_study_id